510(k) · Cleared
Recalled · Class II · 2025BD Phoenix Automated Microbiology System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on May 23, 2002 after a 128-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 118 later devices descend from it. It has been recalled 4 times.
- Decided
- May 23, 2002
- Review
- 128 days
- Class
- Class II
- Product code
- LON
- Recalls
- 4
- Predicates
- 1
118 later devices descend from it, 103 citing it directly.
- This deviceK020321 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- Descendant · cites it directly · 11 of its ownK060324 BD Phoenix Automated Microbiology System for Use with the…Becton, Dickinson & CO · 2006
- Descendant · cites it directly · 10 of its ownK023301 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002 · Recalled
- Descendant · 2 generations on · 9 of its ownK071026 BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007
- Descendant · 2 generations on · 3 of its ownK082140 Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · Recalled
- Descendant · cites it directly · 3 of its ownK043389 BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN)…Becton, Dickinson & CO · 2005
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K060324BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent…Becton, Dickinson & CO · 2006 · cites it directly11descendants
- K023301BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002 · cites it directly10descendants
- K071026BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007 · 2 generations on9descendants
- K082140Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · 2 generations on3descendants
- K043389BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN) 0.5/0.25-32/16UG/MLBecton, Dickinson & CO · 2005 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020321 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| +1 | K060324 | BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent… | Becton, Dickinson & CO | 2006 | — |
| +1 | K023301 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | 2 |
| +2 | K071026 | BD Geneohm Staphsr Assay | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007 | — |
| +2 | K082140 | Xpert Mrsa/SA Blood Culture Assay | Cepheid | 2008 | 2 |
| +1 | K043389 | BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN)… | Becton, Dickinson & CO | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 9 | 0 |
| 2003 | 24 | 0 |
| 2004 | 15 | 0 |
| 2005 | 23 | 0 |
| 2006 | 21 | 0 |
| 2007 | 9 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LON? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LON device
- #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P050510 | VITEK® System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree |
What descends from it? (118)
See all 118103 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060324 | BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent… | 2006 | 11 |
| K023301 | BD Phoenix Automated Microbiology System | 2002 | 10 |
| K043389 | BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN) 0.5/0.25-32/16UG/ML | 2005 | 3 |
| K032675 | BD Phoenix Automated Microbiology System-Cefepime (GN) 0.5-65 UG/ML | 2004 | 3 |
| K032655 | BD Phoenix Automated Microbiology System-Ceftriaxone 0.5-64 UG/ML | 2003 | 3 |
| K031984 | BD Phoenix Automated Microbiology System-Ticarcillin-1-128 UG/ML | 2003 | 3 |
| K031912 | BD Phoenix Automated Micrbiology System Amoxicillin/Clavualante 0.5/0.25-32/16 UG/ML | 2003 | 3 |
| K061327 | BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (GN) 0.5/0.25-32/16… | 2006 | 2 |
| K060444 | BD Phoenix Automated Microbiology System - Cefepime (GN) , Ceftriaxone (GN), Cefotaxime… | 2006 | 2 |
| K052269 | BD Phoenix Automated Microbiology System -Ciprofloxacin GN | 2005 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2025 | Class II | Z-0239-2026 | Software design | Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may… |
| Oct 31, 2024 | Class II | Z-0592-2025 | Software design | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of… |
| Aug 1, 2024 | Class II | Z-3246-2024 | Under Investigation by firm | Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli, |
| Aug 1, 2024 | Class II | Z-3247-2024 | Under Investigation by firm | Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli, |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060324 (Becton, Dickinson & CO, 2006) has gone furthest, with 11 descendants of its own.
How does its category compare?
All LON devicesLON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LON
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LON
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LON
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LON
690in 2025
MAUDE reports naming product code LON, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 19 | 50 | 0 | 3 |
| 2008 | 7 | 66 | 1 | 1 |
| 2009 | 8 | 76 | 0 | 0 |
| 2010 | 1 | — | 116 | 3 |
| 2011 | 8 | 85 | 3 | 4 |
| 2012 | 10 | 200 | 3 | 9 |
| 2013 | 7 | 115 | 0 | 3 |
| 2014 | 4 | 90 | 2 (2) | 10 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 3 | 242 | 2 | 94 |
| 2017 | 10 | 89 | 1 | 197 |
| 2018 | 4 | 88 | 6 | 512 |
| 2019 | 8 | 84 | 1 | 315 |
| 2020 | 5 | 81 | 8 | 218 |
| 2021 | 5 | 268 | 0 | 232 |
| 2022 | 8 | 189 | 15 | 180 |
| 2023 | 11 | 210 | 0 | 453 |
| 2024 | 2 | — | 1 | 418 |
| 2025 | 5 | 90 | 1 | 690 |
| 2026 | 4 | 146 | 6 | — |
What is it indicated for?
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae and most gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus. This premarket notification…
Read the full statement (176 words)
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae and most gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.
This premarket notification is for the addition of the antimicrobial Gatifloxacin at concentrations of 0.25-8 pg to Gram negative and Gram positive ID/AST or AST only Phoenix panels. Gatifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.
Active In Vitro and in Clinical Infections Against:
Aerobic Gram-positive microorganisms
Staphylococcus aureus (methicillin-susceptible strains only)
Aerobic Gram-negative microorganisms
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Active In Vitro Against:
Aerobic Gram-positive microorganisms
Staphylococcus saprophyticus
Aerobic Gram-negative microorganisms
Acinetobacter lwoffii
Citrobacter koseri
Citrobacter freundii
Enterobacter aerogenes
Enterobacter cloacae
Klebsiella oxytoca
Morganella morganii
Proteus vulgaris
Results for Enterobacteriaceae tested with Gatifloxacin should only be reported for isolates recovered from the urinary tract.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020321: BD Phoenix Automated Microbiology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020321
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026